In dental medicine, many treatment materials are typically placed within the oral cavity on the hard (teeth) tissues and soft (inner mucosal epithelium of the cheek, lips, and gingiva and the tongue) tissues.
These treatment materials are placed topically on these tissues or may be inserted (injected) in the space between them, for example, in the naturally occurring sulcus at the tooth/gum line.
These treatment materials are typically applied to the tissues in an “open” manner, namely, without any covering material or containment device. This significantly reduces their desired therapeutic effect as the materials are immediately exposed to saliva contamination (containing numerous pathogenic microorganisms) and salivary washout (or fluid/solids ingestion washout) in a very short time. This time range can be as short as a few seconds to around 10 minutes or more, depending on salivary flow, the viscosity of the treatment material or whether the patient ingests solids or liquids after application of the treatment material.
Additionally, currently known devices use a cover device that covers both the teeth and the gums. These are typically custom made to a specific patient using the following fabrication method. Dental molds are taken of the patient's teeth and surrounding gums and dental stone cast models are poured and allowed to harden. These cast models are removed from the molds and a vacuum-formed thin plastic custom made tray for that specific patient is formed and trimmed to cover over both the teeth and a narrow portion of the surrounding gums. These typically leak the treatment material out of them and also allow saliva to seep inside of them as the stiff material of the tray is difficult to adapt closely to the undulating and varied topography of the teeth and surrounding gums of each individual patient which they are meant to cover.
Additionally, patches onto whose inner surface a thin layer of treatment layer has been adhered are used to cover small areas of the gum tissue. Due to their size they can only treat very limited areas of the soft tissues of the oral cavity and cannot be used to treat the teeth as they cannot be adhered to the teeth structure. They are also easily dislodged by the tongue or contact with the inner cheek and lip muscles.
Additionally, light curable foam materials are manually applied to the gingiva to create a protective barrier against high concentration applications of peroxide for professional teeth whitening treatments. The application of these materials are manually intensive and require a high skill level to apply. Additionally, they are often highly brittle and tend to break or fall off the gingiva and are easily dislodged when even slight pressure or flexing force is applied to them. They are therefore unsuitable to use a gingival barrier in conjunction with an intra-oral mouthpiece.
Additionally, rubber dam barriers consisting typically of some form of latex or rubber sheet or barrier are applied to provide for a “dry field” so as to prevent saliva ingress or moisture contamination during many dental procedures. The rubber dams are typically made of latex rubbers and require manually punched holes by the dentist to allow for them to be placed through the anatomical crown portions of the teeth so as to allow them to drape over the surrounding gum tissue and other oral structures of the oral cavity. These rubber dam barriers are typically fixed or retained in the mouth by using some type of clamping apparatus to secure or anchor the dam barrier in the mouth. These devices are typically very cumbersome and very large, uncomfortable for the patient and due to their size and coverage of large areas of the intra-oral anatomical structures, preclude their use in conjunction with the insertion of an intra-oral mouthpiece in the mouth.
It is an object of the present invention to provide an improved device that aims to overcome or at least alleviate the above mentioned drawbacks.